Abstract 1998
Background
Radium-223 (Ra-223) 50 kBq/kg IV (55 kBq/kg after NIST update) every 4 wk × 6 injections (inj) is indicated in symptomatic bone-metastatic castration-resistant prostate cancer (mCRPC) patients (pts) with no visceral metastases (mets). In an international prospective trial in mCRPC pts (NCT01934790), Ra-223 re-treatment (re-tx) after initial 6 inj was well tolerated, with very low radiologic bone progression rates (Sartor. ASCO GU 2016). Reported are safety and total alkaline phosphatase (ALP) and prostate-specific antigen (PSA) dynamics.
Methods
All pts had CRPC with bone mets and completed 6 Ra-223 inj with no bone progression during that initial tx. Pts had radiologic or clinical progression after initial Ra-223 tx, and adequate hematologic (heme) values. Pts who started subsequent anticancer tx must have progressed on the last anticancer tx. Concomitant agents (except cytotoxic) were allowed at investigator discretion. Addition of abiraterone and enzalutamide was not allowed during Ra-223 re-tx. Primary end point was safety; exploratory efficacy end points included times to ALP and PSA progression, and ALP and PSA response rates (≥30% decline from baseline).
| Re-tx Study, N = 44 | Re-tx Study, N = 44 | Re-tx Study, N = 44 | ALSYMPCA Ra-223 Arm, N = 600 | ALSYMPCA Ra-223 Arm, N = 600 | ALSYMPCA Ra-223 Arm, N = 600 | |
|---|---|---|---|---|---|---|
| Treatment-emergent adverse events* | All Gr | Gr 3 | Gr 4 | All Gr | Gr 3 | Gr 4 |
| ≥1 TEAE, %† | 93 | 41 | 7 | 93 | 35 | 9 |
| Heme, % | ||||||
| Anemia | 14 | 5 | 0 | 31 | 11 | 2 |
| Thrombocytopenia | 2 | 2 | 0 | 12 | 3 | 3 |
| Neutropenia | 0 | 0 | 0 | 5 | 2 | 1 |
| Leukopenia | 2 | 0 | 0 | 4 | 1 | 20% pts §ALSYMPCA intent-to-treat population ‖n/N = pts with response/pts with valid lab assessment ¶For ALSYMPCA, ALP response: ≥ 30% decline from baseline confirmed by a second measurement ≥4 wk later; PSA response: ≥ 30% decline from baseline # ALSYMPCA: End of tx (4 wks after last inj) **N = safety population; pts with no valid postbaseline lab assessment counted as nonresponders; database cutoff date was June 11, 2015 NA = not applicable
ResultsOf 44 Ra-223 re-tx pts, 29 (66%) received all 6 inj. Median time from last inj of initial Ra-223 tx was 6 mo. There were no marked alterations in tx-emergent adverse event (TEAE) incidence vs ALSYMPCA (Table) and no grade 4 or 5 heme TEAEs; 3 (7%) re-tx pts had grade 3 or 4 tx-related TEAEs. Maximum follow-up times for ALP and PSA progression were 12.8 and 11.4 mo, respectively. Median time to ALP progression was not reached. Median time to PSA progression was 2 mo. ALP and PSA response rates at wk 12, 24, and any time before database cutoff are reported (Table). ALP, PSA, and heme lab values will be reported. ConclusionsRa-223 re-tx was well tolerated, with minimal heme toxicity and ALP and PSA profiles similar to those of ALSYMPCA. Clinical trial identificationNCT01934790 Legal entity responsible for the studyPharmaceuticals Division of Bayer FundingPharmaceuticals Division of Bayer DisclosureO. Sartor: Consultant or advisory role for Astellas, Bavarian Nordic, Bayer, Bellicum, Biscayne, Johnson & Johnson, Medivation, Oncogenex, Sanofi, Algeta, Aragon, and Pfizer; research funding from Bayer, Johnson & Johnson, Progenics, Sanofi, Algeta, and Takeda. D. Heinrich: Honoraria from and consultant or advisor for Bayer, Johnson & Johnson, and Astellas; research funding from Bayer, Johnson & Johnson, BMS, and Aragon Pharmaceuticals. N. Mariados: Stock or ownership interest in and travel, accommodations, expenses from Augmenix; honoraria from and speakers bureau for Bayer. M.J. Méndez Vidal: Consulting or advisory role for Janssen-Cilag, Pfizer, Astellas, GlaxoSmithKline, Sanofi, and Bayer; travel, accommodations, expenses from Janssen-Cilag, Pfizer, Astellas, and GlaxoSmithKline. D. Keizman: Consulting or advisory role for, honoraria from, and travel, accommodations, and expenses from Bayer, Pfizer, Sanofi, and Janssen Oncology. C. Thellenberg Karlsson: Consulting or advisory role for Bayer and Sanofi. G. Procopio: Consulting or advisory role for Janssen, Novartis, and Bayer; honoraria from Astellas and Janssen. S. Severi: Speakers bureau for Bayer. V. Wagner: Was employed by Merck; is now employed by Bayer; stock or other ownership in Bayer, Merck, and Amgen. J. Garcia-Vargas: Employed by Bayer; travel, accommodations, expenses from Bayer. R. Li: Employed by Bayer. All other authors have declared no conflicts of interest. Resources from the same sessionZUMA-3: A phase 1/2 multi-center study evaluation the safety and efficacy of KTE-C19 anti-CD19 CAR T cells in adult patients with relapsed/refractory B precursor acute lymphoblastic leukemia (R/R ALL)Presenter: Bijal Shah Session: Poster display Resources: Abstract ZUMA-2: A phase 2 multi-center study evaluating the efficacy of KTE-C19 (Anti-CD19 CAR T cells) in patients with relapsed/refractory Mantle cell lymphoma (R/R MCL)Presenter: Michael Wang Session: Poster Display Resources: Abstract ZUMA-1: A phase 2 multi-center study evaluating anti-CD19 chimeric antigen receptor (CAR) T cells in patients with refractory aggressive non-Hodgkin lymphoma (NHL)Presenter: Sattva Neelapu Session: Poster Display Resources: Abstract Younger age as a prognostic indicator in breast cancer: Correlation between clinical-pathologic factors and miRNAs and long-term follow-upPresenter: Maria Teresa Martinez Session: Poster display Resources: Abstract Window study of the PARP inhibitor rucaparib in patients with primary triple negative or BRCA1/2 related breast cancer (RIO)Presenter: Christy Toms Session: Poster display Resources: Abstract Whole exome sequencing (WES) and RNA sequencing (RNA-seq) in routine clinical practice for colorectal cancer (CRC) and non-small cell lung cancer (NSCLC) patients (pts)Presenter: Géraldine Perkins Session: Poster display Resources: Abstract What is the optimal annual interpretive volume for a radiologist reading screening mammograms?Presenter: Asli Uluturk Session: Poster display Resources: Abstract What decides breast conservation versus mastectomy in the background of diverse sociocultural environment, an Indian studyPresenter: Poonamalle Padmanabhan Bapsy Session: Poster display Resources: Abstract Waiting time to diagnosis and treatment of the head and neck cancer in four institutions in PortugalPresenter: Ana Castro Session: Poster display Resources: Abstract Wait times for diagnosis and treatment of lung cancer: a single centre experiencePresenter: Catherine Labbe Session: Poster Display Resources: Abstract This site uses cookies. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used. For more detailed information on the cookies we use, please check our Privacy Policy.
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